Ginette 35 is a prescription medication combining cyproterone acetate and ethinylestradiol, primarily indicated for the treatment of androgen-dependent conditions in women. It is widely recognized for its efficacy in managing moderate to severe acne, hirsutism, and seborrhoea, particularly when these conditions are resistant to topical treatments. Additionally, it serves as an oral contraceptive, offering a dual therapeutic benefit. This product card provides a detailed, expert-level overview of Ginette 35, covering its features, benefits, usage, and safety profile to support informed medical decision-making.

Features

• Contains 2 mg cyproterone acetate and 0.035 mg ethinylestradiol per tablet
• Packaged in a calendar blister of 21 active tablets
• Oral administration; designed for once-daily intake
• Requires prescription and medical supervision
• Manufactured under strict pharmaceutical quality standards
• Hormonal composition tailored to suppress androgen activity

Benefits

• Effectively reduces symptoms of androgen excess, such as acne and unwanted hair growth
• Provides reliable contraception with a Pearl Index of approximately 0.5–1.0 when taken correctly
• Helps regulate menstrual cycles and reduce menstrual pain for many users
• Can improve skin oiliness and related dermatological concerns
• Offers a combined therapeutic approach for both dermatological and gynecological health
• May contribute to enhanced quality of life and self-esteem by addressing visible symptoms

Common use

Ginette 35 is primarily prescribed for women of reproductive age experiencing moderate to severe acne vulgaris, hirsutism, or seborrhoea related to androgen sensitivity, where other treatments have proven insufficient. It is also utilized as an oral contraceptive. It is not intended for use in postmenopausal women, adolescents before menarche, or as a primary treatment for non-androgen-related conditions. Use should be initiated under medical guidance following a thorough health assessment.

Dosage and direction

Take one tablet daily at approximately the same time each day for 21 consecutive days, followed by a 7-day tablet-free interval. Menstrual-like withdrawal bleeding usually occurs during this break. Start the next pack on the 8th day, even if bleeding has not ceased. It is advisable to begin on the first day of the menstrual cycle for immediate contraceptive protection. If switching from another hormonal contraceptive, follow specific medical instructions to ensure continuity and efficacy.

Precautions

• Not suitable during pregnancy or breastfeeding
• Regular medical check-ups are recommended, including blood pressure monitoring and breast examinations
• Caution advised in women with a history of depression, migraines, or cardiovascular risk factors
• May affect glucose tolerance; monitor in diabetic patients
• Discontinue use if jaundice, significant hypertension, or severe headaches occur
• Inform healthcare provider of any upcoming surgery or prolonged immobilization

Contraindications

• History of venous or arterial thrombosis
• Severe hepatic disease or liver tumors
• Known or suspected hormone-dependent malignancies
• Undiagnosed abnormal vaginal bleeding
• Hypersensitivity to any component of Ginette 35
• Pancreatitis with severe hypertriglyceridemia

Possible side effect

Common side effects may include nausea, headache, breast tenderness, mood changes, and weight fluctuations. Less frequently, users may experience hypertension, glucose intolerance, or altered libido. Rare but serious risks include thromboembolic events, hepatic disorders, and cardiovascular complications. Any persistent or severe symptoms should prompt immediate medical consultation.

Drug interaction

Ginette 35 may interact with enzyme-inducing drugs (e.g., rifampicin, certain anticonvulsants, St. John’s Wort), reducing its efficacy. Broad-spectrum antibiotics and some antifungals might also impact contraceptive reliability. Concurrent use with other hormonal therapies is not recommended. Always disclose all medications, including over-the-counter and herbal products, to the prescribing physician.

Missed dose

If a tablet is missed and less than 12 hours have passed, take it immediately and continue the schedule. If more than 12 hours late, efficacy may be reduced; take the missed tablet as soon as possible and use additional contraceptive precautions (e.g., condoms) for the next 7 days. Consult the package leaflet or a healthcare provider for specific guidance based on the cycle day missed.

Overdose

Overdose may cause nausea, vomiting, or withdrawal bleeding. There is no specific antidote; symptomatic treatment is recommended. Serious effects are unlikely due to the hormonal composition, but medical advice should be sought if large quantities are ingested.

Storage

Store below 25°C in a dry place, protected from light. Keep out of reach of children. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is for educational purposes and does not replace professional medical advice. Always consult a healthcare provider for diagnosis, treatment decisions, and personalized guidance. Use strictly as prescribed.

Reviews

Clinical studies and patient reports generally indicate high satisfaction with Ginette 35 for its dermatological benefits and contraceptive reliability. Some users note initial side effects like nausea or mood changes, which often subside after several cycles. Long-term users appreciate the improvement in skin condition and menstrual regularity. Individual experiences may vary; adherence to medical supervision is crucial for optimal outcomes.